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Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Irritable Colon; Irritable Bowel Syndrome (IBS)

Intervention: alosetron (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

The purpose of this study is to compare the safety and effectiveness of as needed versus fixed dosing of an investigational medication for women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed conventional therapy.

Clinical Details

Official title: A 12-Week, Randomized, Double-Blind, Placebo- Controlled Study of PRN BID and Fixed Dosing Regimens of Alosetron in Female Subjects With Severe Diarrhea-Predominant Irritable Bowel Syndrome Who Have Failed Conventional Therapy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Subject self assessment of improvement between treatment groups using the IBS Global Improvement Scale; comparison of safety and tolerability between treatment groups with respect to adverse events & laboratory abnormalities.

Secondary outcome: Comparison of treatment groups with respect to subject relief of IBS pain & discomfort; lower GI symptoms, changes in quality of life, lost workplace productivity, & lost household/leisure activity, & subject satisfaction with assigned study drug.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS).

- Failed conventional therapy.

- Willing to make daily calls on a touch-tone telephone.

Exclusion criteria:

- History of or current chronic or severe constipation.

- Bloody diarrhea, abdominal pain with rectal bleeding.

- Thrombophlebitis.

- Abnormal thyroid stimulating hormone (TSH) value.

- Alcohol and/or substance abuse within past two years.

- Pregnant or lactating.

- History/treatment of malignancy within past five years.

Locations and Contacts

GSK Investigational Site, Birmingham, Alabama 35235, United States

GSK Investigational Site, Birmingham, Alabama 35242, United States

GSK Investigational Site, Huntsville, Alabama 35801, United States

GSK Investigational Site, Mobile, Alabama 36693, United States

GSK Investigational Site, Pell City, Alabama 35125, United States

GSK Investigational Site, Tallassee, Alabama 36078, United States

GSK Investigational Site, Tucson, Arizona 85712, United States

GSK Investigational Site, Little Rock, Arkansas 72205, United States

GSK Investigational Site, North Little Rock, Arkansas 72117, United States

GSK Investigational Site, Beverly Hills, California 90211, United States

GSK Investigational Site, Carlsbad, California 92008, United States

GSK Investigational Site, Concord, California 94520, United States

GSK Investigational Site, Encinitas, California 92024, United States

GSK Investigational Site, Fresno, California 93720, United States

GSK Investigational Site, Garden Grove, California 92840, United States

GSK Investigational Site, Los Angeles, California 90035, United States

GSK Investigational Site, Orange, California 92868, United States

GSK Investigational Site, Roseville, California 95661, United States

GSK Investigational Site, San Diego, California 92103, United States

GSK Investigational Site, San Diego, California 92108, United States

GSK Investigational Site, San Diego, California 92120, United States

GSK Investigational Site, San Francisco, California 94114, United States

GSK Investigational Site, San Francisco, California 94115, United States

GSK Investigational Site, San Francisco, California 94122, United States

GSK Investigational Site, Santa Ana, California 92704, United States

GSK Investigational Site, Spring Valley, California 91978, United States

GSK Investigational Site, Torrance, California 90505, United States

GSK Investigational Site, Van Nuys, California 91405, United States

GSK Investigational Site, Centennial, Colorado 80112, United States

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GSK Investigational Site, Bristol, Connecticut 06010, United States

GSK Investigational Site, Belleair Bluffs, Florida 33770, United States

GSK Investigational Site, Boca Raton, Florida 33428, United States

GSK Investigational Site, Bradenton, Florida 34209, United States

GSK Investigational Site, Clearwater, Florida 33756, United States

GSK Investigational Site, Clearwater, Florida 33765, United States

GSK Investigational Site, Deland, Florida 32720, United States

GSK Investigational Site, Gainesville, Florida 32607, United States

GSK Investigational Site, Hollywood, Florida 33021, United States

GSK Investigational Site, Jacksonville, Florida 32209, United States

GSK Investigational Site, Jacksonville, Florida 32256-6004, United States

GSK Investigational Site, Kissimmee, Florida 34741, United States

GSK Investigational Site, Melbourne, Florida 32901, United States

GSK Investigational Site, North Miami Beach, Florida 33162, United States

GSK Investigational Site, Spring Hill, Florida 34608, United States

GSK Investigational Site, Stuart, Florida 34996, United States

GSK Investigational Site, Zephyrhills, Florida 33540, United States

GSK Investigational Site, Atlanta, Georgia 30328, United States

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GSK Investigational Site, Blue Ridge, Georgia 30513, United States

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GSK Investigational Site, Fayetteville, Georgia 30214, United States

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GSK Investigational Site, Indianapolis, Indiana 46208, United States

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GSK Investigational Site, Jeffersonville, Indiana 47130, United States

GSK Investigational Site, Clive, Iowa 50325, United States

GSK Investigational Site, Haysville, Kansas 67060, United States

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GSK Investigational Site, Florence, Kentucky 41042, United States

GSK Investigational Site, Lexington, Kentucky 40508, United States

GSK Investigational Site, Lexington, Kentucky 40536, United States

GSK Investigational Site, Madisonville, Kentucky 42431, United States

GSK Investigational Site, Covington, Louisiana 70433, United States

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GSK Investigational Site, New Orleans, Louisiana 70128, United States

GSK Investigational Site, New Orleans, Louisiana 70112, United States

GSK Investigational Site, Shreveport, Louisiana 71103, United States

GSK Investigational Site, Annapolis, Maryland 21401, United States

GSK Investigational Site, Baltimore, Maryland 21229, United States

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GSK Investigational Site, Lanham, Maryland 20706, United States

GSK Investigational Site, Oxon Hill, Maryland 20745, United States

GSK Investigational Site, Severna Park, Maryland 21146, United States

GSK Investigational Site, Silver Spring, Maryland 20910, United States

GSK Investigational Site, Towson, Maryland 21204-7736, United States

GSK Investigational Site, Towson, Maryland 21204, United States

GSK Investigational Site, Wheaton, Maryland 20906, United States

GSK Investigational Site, Burlington, Massachusetts 01805, United States

GSK Investigational Site, Farmington Hills, Michigan 48334, United States

GSK Investigational Site, Northville, Michigan 48167, United States

GSK Investigational Site, Petoskey, Michigan 49770, United States

GSK Investigational Site, Saginaw, Michigan 48602, United States

GSK Investigational Site, Brooklyn Center, Minnesota 55430, United States

GSK Investigational Site, Chesterfield, Missouri 63017, United States

GSK Investigational Site, St. Louis, Missouri 63141, United States

GSK Investigational Site, Lincoln, Nebraska 68503, United States

GSK Investigational Site, Omaha, Nebraska 68144, United States

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GSK Investigational Site, Berlin, New Jersey 08009, United States

GSK Investigational Site, Blackwood, New Jersey 08012, United States

GSK Investigational Site, Cedar Knolls, New Jersey 7927, United States

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GSK Investigational Site, South Bound Brook, New Jersey 08880, United States

GSK Investigational Site, Willingboro, New Jersey 08046, United States

GSK Investigational Site, Albuquerque, New Mexico 87106, United States

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GSK Investigational Site, Portland, Oregon 97225, United States

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GSK Investigational Site, Kingsport, Tennessee 37660, United States

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GSK Investigational Site, Nashville, Tennessee 37205, United States

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GSK Investigational Site, Dallas, Texas 75230, United States

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GSK Investigational Site, Humble, Texas 77338, United States

GSK Investigational Site, North Richland Hills, Texas 76180, United States

GSK Investigational Site, Pasadena, Texas 77505, United States

GSK Investigational Site, San Antonio, Texas 78205, United States

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GSK Investigational Site, Salt Lake City, Utah 84132, United States

GSK Investigational Site, Chesapeake, Virginia 23320, United States

GSK Investigational Site, Christiansburg, Virginia 24073, United States

GSK Investigational Site, Danville, Virginia 24541, United States

GSK Investigational Site, Norfolk, Virginia 23502, United States

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GSK Investigational Site, Weber City, Virginia 24290, United States

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GSK Investigational Site, Nedlands, Western Australia 27408, Australia

GSK Investigational Site, La Crosse, Wisconsin 54601, United States

GSK Investigational Site, Madison, Wisconsin 53792, United States

Additional Information

Starting date: June 2003
Last updated: April 15, 2015

Page last updated: August 23, 2015

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